Prsentation PowerPoint

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Derogations under the Detergents Regulation
Stephen Pickering
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Biodegradability requirements

• Ultimate biodegradability
• Ultimate biodegradatation breakdown to CO2,
  H2O, mineral salts and increased biomass
• (Primary biodegradatation loss of surfactant
  characteristics)
• Criterion for ultimate biodegradability 60 in
  28 days
• Same criterion applies to all types of surfactant
  i.e. ionic, anionic, cationic and amphoteric

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Derogation decision tree
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Granting of derogations

• Derogations may be granted if
• Used in low-dispersive applications
• Used in specific II applications only
• Risk to environment is small compared to
  socio-economic benefits
• (the availability of alternatives is no reason to
  refuse a derogation)
• - Derogations may allow, limit, or severely
  restrict use.
• - Restrictions may include a phase-out period.

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Derogation granted Dehypon G 2084

• Alcohols, Guerbet, C16-20, ethoxylated, n-butyl
  ether (7-8EO) Dehypon G 2084 for
• Bottle washing (160t/year)
• Cleaning-in-place (40t/year)
• Metal cleaning (40t/year)
• Commission Regulation (EC) No 551/2009

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Characteristics of Dehypon G 2084

• Primary biodegradability 95 in 19 days the
  metabolites are
• n-butanol
• ethoxylates
• guerbet alcohol
• Ultimate biodegradability of 42 in 28 days

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Tiered approach to testing

• Tier 1 worst-case assumptions. No specific
  knowledge of metabolites needed.
• Tier 2 basic understanding of metabolites.
  Assessment of mixture of data interpolation.
• Tier 3 full knowledge of metabolites. Full risk
  assessment.

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Toxicity testing of Dehypon G 2084

• Toxicity testing
• algae
• Daphnia acute
• Daphnia chronic (most sensitive NOEC 0.1 mg/l)
• fish
• PEC/PNEC lt1 with safety factor 100

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Reasons for derogation

• Request for three named uses evaluated by German
  competent authority which found
• Uses are low dispersive
• The uses are industrial
• No risk to the environment as the surfactant
  poses no risk (lack of toxicity) and its
  metabolites are not persistent

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Opinion of the Committee

• Committee agrees with German evaluation but notes
  that only partial information is available on the
  toxicity of the metabolites
• Committee notes that no suitable alternatives are
  available
• Committee decides to limit the duration of the
  derogation to 10 years to encourage development
  of alternatives

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Other applications for derogation

• A small number of other applications for
  derogation were made (in France and Sweden) but
  those were subsequently abandoned
• one use was found to fall outside the scope of
  the Regulation (fuel additive)
• for the others only incomplete dossiers were
  submitted before the deadline and the application
  automatically lapsed